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FDA 510(k), K180337, EUROPA Pedicle Screw System
FDA 510(k), K180337, EUROPA Pedicle Screw System
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510(K) Number: K180337
Device Name: EUROPA Pedicle Screw System
Manufacturer: MiRus, LLC
Device Classification Name: thoracolumbosacral pedicle screw system
Regulation Number: 888.3070
Classification Product Code: NKB
Date Received: 02/07/2018
Decision Date: 03/14/2019
Regulation Medical Specialty: Orthopedic
Device Name: EUROPA Pedicle Screw System
Manufacturer: MiRus, LLC
Device Classification Name: thoracolumbosacral pedicle screw system
Regulation Number: 888.3070
Classification Product Code: NKB
Date Received: 02/07/2018
Decision Date: 03/14/2019
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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